A Pharmaceutical Company is seeking a Research Associate in Frederick, MD. Role Description This role will provide process engineering and analytical support for commercial manufacturing of cell therapy. Working cross functionally with quality, operations, material management, facility and engineering functions, the role is expected to provide technical input for product/process response and investigations, technology implementation, technology transfers, process validation and regulatory filings. • Execute scientific laboratory studies to support process/product understanding and continuous improvement projects • Execute analytical testing of cell therapy products – flow cytometry, ELISA and PCR assays. • Ability to follow laboratory procedures with attention to detail, and successfully execute experiments at the bench • Provide technical input to the execution of process validation and comparability campaigns. • Participate in evaluation of new technology and process automation for introduction into GMP manufacturing • Participate and support process FMEAs to understand process and product risks as a pre-requisite for process validation. • Participate and report to a cross-functional team to advance production activities. • Participate in Operational Excellence activities within Tier Structure. • Participate continuous improvement projects supporting commercial manufacturing site • Ensure systematic DMAIC based approach utilization for process/product related investigations to identify root cause and provide impact assessment to maintain routine manufacturing operations and determine process improvements for manufacturing. • Support technology transfers of launch and commercial cell therapy products • Effectively & efficiently communicate manufacturing process performance internally. • Support the implementation of automation and IT infrastructure projects • Assist in writing technical documentation (protocols & reports for equipment/instrument qualifications, comparability, and cell therapy manufacturing process validation) Skills & Requirements • Bachelors Degree in Biochemical Engineering, Tumor Immunology, Biotechnology or Life Sciences. • Basic understanding in Bioprocessing, Cell Culture and Biochemistry. • Knowledge of ELISA and/or PCR testing • Knowledge in flow cytometry and data analysis (FACSDiva, FlowJo, GraphPad Prism, Excel) is a plus • Ability to think critically, demonstrate troubleshooting and problem-solving skills • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment • Previous experience with other technologies is a plus • Experience with the use of Microsoft word, Excel, Power Point, Smartsheet, Prism, JMP, and other data analysis applications • Highly collaborative with excellent interpersonal, verbal and written communication skills • Ability to think critically with demonstrated problem-solving and troubleshooting skills • Comfortable working in a fast-paced company environment with minimal direction and able to adjust workload/assignments based upon changing priorities • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description
HAYS PLC • Frederick, U.S.
A Pharmaceutical Company is seeking a Research Associate in Seattle, WA.Role Description• Design and Develop analytical methods for characterizing on-target and off-target genome modifications in engineered T cells.• Qualify, transfer, validate related analytical methods including training of additional operators• Design and execute experiments as needed including sample testing• Collaborate with others to handle day to day operation of the laboratory to ensure smooth operation.• Maintain accurate and detailed electronic laboratory notebook and author technical and regulatory documents.• Present experimental data in internal or external meetings.Skills & Requirements• B.S. in Molecular Biology or other related biological science disciplines with experience in molecular biology-related studies, or MS in molecular biology or related fields.• Skillful with molecular biology techniques (cloning, construct design, primer/probe design, qPCR, RT-PCR).• Ability to carefully follow existing methods and SOPs and ability to design experiments of higher complexity.• Ability to generate meticulous experimental record, study report, SOP, and other documents.• Strong sense of responsibility, accountability, and integrity.• Strong time management skills with the capacity to prioritize work from multiple projects to meet deadlines.Preferred Qualifications• Working knowledge of electronic laboratory notebook software and DNA analysis software for primer/probe design• Experience with droplet digital PCR (ddPCR)Why Hays?You will be working with a professional recruiter who has intimate knowledge of the Information Technology industry and market trends . Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.Additionally, this position is a contract role where Hays offers you the opportunity to enroll in full medical, dental or vision benefits.• Medical• Dental• Vision• 401K• Life Insurance ($20,000 benefit)
HAYS PLC • Seattle, Stati Uniti
A Pharmaceutical Company is seeking an Research Associate /Senior Research Associate – Translational Biology in Lexington, MA. Role Description • Play a role in guiding creative and rigorous biological research programs aimed at fully understanding the disease mechanism of our pipeline. • Conduct efficacy, pharmacokinetic, pharmacodynamics, structure-activity-relationship and mechanisms of action studies of drug candidates • Use appropriate in vivo models to understand the mechanisms by which our drug candidates may contribute to adverse events in patients • Present working progress to team members in group meeting • Work closely with members of our research team to develop in vivo strategies to quickly and effectively address key questions related to the safety and efficacy of our drugs. • Review literature and provide insights to research directions, while predominantly making hands-on contributions to the research Skills & Requirements • Bachelor’s or Master’s Degree in Biology, Pharmacology, or related field, with a minimum of 1-3 years of experience. • Proficient in animal handling, dosing and surgery. Proficient in techniques including but not limited to oral gavage, intravenous injection, subcutaneous injection, blood collection and basic surgery • In depth knowledge of, and hands-on experience with, in vitro and in vivo models used for mechanistic investigation with small molecule or RNAi therapeutics • Experience performing molecular and cellular biology techniques, including but not limited to RNA preparation, RT-qPCR, ELISA, immunohistochemistry, urine biomarker analysis, plasma biomarker analysis • Broad and deep understanding of signaling pathways and biological processes implicated in rare genetic liver diseases as well as the mechanism of action of RNAi therapies is desirable • Previous experience in drug discovery is preferred • Outstanding written and oral communication skills • A high level of motivation and demonstrated record of accomplishment throughout your career • The ability to work effectively as part of a team, in a fast-paced environment
HAYS PLC • Lexington, U.S.
The Researcher will manage the implementation of research activities in Brazil. The Researcher will have a strong focus on how vulnerable and marginalized groups communicate to access information about COVID-19-related issues and how their use of online media intersects with their use of traditional media and other sources. Research activities include desk research, social media monitoring, Key Informant Interviews, Focus Group Discussions, surveys, capacity assessment interviews and field observations. The research will help to inform public health and humanitarian response agencies to better communicate key messages to the at-risk population.DAY-TO-DAY TASKS will include:Work closely with the Lead Researcher, Social Scientist and Project Manager to design research activities;Adapt research tools to the local context;Coordinate with partner organizations to provide training to ensure quality data collection practices;Clean, collate and analyze data collected by staff and partner organizations;Conduct key informant interviews with community leaders, influencers, public health and humanitarian agency officials, media representatives, and others;Identify information flows, uses, popular platforms, trusted actors, and how information on the virus is produced, distributed, and accessed;Contribute to the writing of the final report;Generate graphs or other engaging content to display data;Deliver regular reporting to the project team;Perform any other duties as assigned by supervisors; andUnderstanding of and demonstrated commitment to upholdingQUALIFICATIONS WE'RE LOOKING FORStrong Monitoring and Evaluation, Research and Learning (MERL) background, especially using a mix of qualitative and quantitative, observational participatory data collection and analysis methods, working in complex, humanitarian contextsMaster's degree in social sciences, international development, evaluation, or a related fieldAt least five years of experience conducting project/program impact evaluationFluency in written and spoken Portuguese and EnglishDirect research experience with Indigenous and Afro-Brazilian communities located in Northern Brazil is a plusExcellent intercultural communication skills/cultural sensitivity and the ability to forge strong cross-cultural relationships and build trust demonstrated through previous experienceStrong co-design facilitation, presentation, writing and communication skillsFamiliarity with the latest research on mis- and disinformation, trust and related research emerging from political, social and communication sciencesStrong understanding of the humanitarian principles to ensure data collection and provision follow the Core Humanitarian StandardsRelevant experience working with data collection and analysis software, including Kobo Toolbox or similar softwareData visualization skills and knowledge of relevant software to produce infographics, a plusStrong software skills to ensure proper design and layout of the regular reports, a plusSelf-motivated and used to work in a fast-paced environment
Glassdoor Inc. • Rio De Janeiro, Brazil
Afin de renforcer leur équipe, mon client spécialisé dans la production d’outils de filetage, recherche un(e) ingénieur R&D.Vos Missions:Vous assurez le développement et la spécification de leurs produitsVous suivez le traitement des demandes clients et des attentes du marchéVous assurez le support technique en collaboration avec le service clientVotre Profil:Formation technique (Polymécanicien ou micromécanicien) – diplôme ES en mécaniqueMinimum 3 ans d’expérience dans le domaineDe langue maternelle française – allemand ou anglais un plusBonnes connaissance 3D CAD Vous vous êtes reconnu dans ce descriptif ?N’attendez plus pour m’envoyer votre dossier complet ! https://www.approachpeople.com/job/ingenieure-rd-polymecanicien/
Approach People Recruitment • Berne, Suisse
Remote - Mobile Apps CI/CD DevOps Engineer - 12 months+ contract - W2 submissions only (no third party/ C2C submissions allowed)Seeking a talented DevOps Engineer Ld with mobile application experience to join our Infrastructure Services Team for the Mobile Native Apps platform.Role: This DevOps Engineer will be maintaining, architecting, and implementing our continuous integration pipeline to drive the development and automated testing of mobile iOS and Android applications.Will have the opportunity to work with a group of top-notch mobile software and test engineers. To be successful in this role, the candidate must be hands-on, proactive, good at problem solving, and have a strong desire to learn and drive for results.Duties will primarily be improving software delivery practices around continuous integration and testing of code.Developing build, test and deployment scripts and designing infrastructure and application configurations for continuous integration and delivery.In addition, responsible for monitoring and reporting on the health of the CI/CD pipelines and seeking out ways to continuously improve the performance of them and the productivity of 9 scrum teams.As part of the Enterprise Monitoring Team, help to deliver best in class monitoring capabilities and services to improve the maturity of performance, availability, and capacity management processes for both the applications and infrastructure components.As an Agile delivery team member, provide customers with the near real time observability needed to rapidly respond to events, while advancing the client's monitoring capabilities. Assist in evaluating, designing, and implementing software products to support customer requirements, as well as perform research and development efforts pertaining to new features and capabilities.Required skills:* 2+ years of experience with mobile apps (iOS and Android) build systems & deployment.* Experience with industry CI/CD tools (e.g., Azure DevOps, Teamcity, Buildkite, Bitrise, Github Actions, CircleCI, etc.).* Experience with cloud build agents for Mac (e.g., AWS EC2, Mac in Cloud, etc.) is a plus.* Knowledge of package and configuration management tools (Terraform, Puppet, Ansible, etc.) and containers such as Docker (compose, private registries).Preferred skills and experiences:* Experience with package distribution systems (Nexus, Artifactory, etc.)* Proficient with at least one scripting language (Bash, Python, Shell, etc.)* Solid experience with packaging components (Cocoapods/Jar) and distributing them to internal and external customers* Strong understanding of Git development workflows and branchingDay-to-Day Responsibilities:* Maintain and enhance our Android and iOS CI/CD build and release orchestration scripts and tools. Current stack:o Azure Dev Ops (ADO).o Automated testing tools (Espresso, KIF).o Fastlane and Gradle.* Research and recommend improvements for static analysis solutions for linting, accessibility, performance, security, etc. to improve CI/CD capabilities.* Automate manual processes in our build, test, and release stages.* Own tooling roadmaps to introduce new tools and take advantage of new features for current tools.* Monitor build times to ensure they stay within established ranges.* Participate in coordination and release of production deployments.
Careerbuilder • Cleveland, U.S.
South Dakota State UniversityPhysical Location of Position (City): Beresford (SD)Posting TextJob Responsibilities: This position will work with diverse research projects at the SDSU Southeast Research Farm in Beresford, SD. The primary focus will be on cropping systems research with both agronomic and horticultural crops at the farm; to engage with livestock and other farm research and maintenance efforts as directed by the Operations Manager; implement assigned trials, including collecting and storing samples, recording data, and providing for field and plot maintenance, and equipment as directed and based on protocols provided by SDSU researchers; summarize data collected and transmit it to project directors, and assist with analysis and interpretation of data; help prepare presentations and reports in coordination with the project director and the operations manager of the farm. Knowledge, Skills & Abilities:Knowledge of:Commercial crop or vegetable productionFarm equipment operation and maintenanceAgronomic or horticultural researchData management and software for controlling precision ag equipmentSkill & Ability to:Demonstrate ability to work with famers and other clientele groupsWork in the field and to travel as needed to complete assigned tasksBe self-motivated, disciplined, and ale to understand and adhere to research protocolsWork independently on a day-to-day basisRequired License: Valid driver’s license. Commercial pesticide applicator license within 6 months of hire.
Glassdoor Inc. • Brookings, U.S.
An American Company is seeking an Sr CRA – Ophthalmology in Rockville, MD. Role Description he Senior Clinical Research Associate (Sr. CRA) will work closely with the Clinical Project manager and is responsible for assisting in the planning and execution of clinical trials which includes assistance in vendor and site management, coordinating or leading data review and cleaning. Will support the CPM with oversight of the clinical study while ensuring the trial is conducted in compliance with the protocol, ICG/GCP, applicable regulatory requirements and applicable SOPs/Work instructions. Candidates must have the ability to prioritize multiple tasks based on workload, work in a fast-paced environment, have strong computer skills (Word Document, Excel and Power Point), maintain completion of required corporate training on standards, policies, work instructions due date. • May act as primary point of contact for specific vendors investigational sites as needed • Create, implement, and maintain systems to track study metrics and general information relating to study execution. Provides the updates to the team on metrics as needed • Prepare trial-related documents including but not limited to Informed Consent Forms (ICF), source documents, patient instruction guides, lab manuals and Case Report Forms (CRFs) • Reviews site-specific study documents (site-specific ICF and study tools/worksheets), , and site payments • Works closely with enablement group and clinical project manager to track study metrics including CRO and other vendor activities • Conduct periodic review of metrics for completion of study files in the eTMF. Escalates appropriately to the CPM and study team of updates and timelines regarding file completion. • Participates in team meetings and may lead small operational teams and/or participates in collaborative efforts (e.g. Standard Operating Procedure (SOP) development, operational task forces, etc.) • Supports Clinical Project Manager in site and vendor selection process, training and evaluation of study personnel (contractors and CRO). • May participate in site visits as needed or accompany experienced clinical monitor for co-monitoring or training purposes • Collaborated with internal cross functional teams to ensure effective delivery of the assigned project milestones • Organizes internal team meetings, investigator, meeting and other trial specific meetings as required • Support the clinical project manager in the planning and organization of investigator meetings and other meetings as necessary • Provides support to the Clinical Project Manager in the management of vendor scope(s) of work, budget updates & reconciliation, as agreed upon with prospectively established milestones and timelines • Maintain completion of required corporate training on standard, policies and work instructions by due date • Generate purchase orders, process vendor invoices and assist in tracking spend approved in the budget • Performs other work-related duties as assigned Skills & Requirements • BS/BA degree in scientific discipline or related healthcare field is preferred but not required; however, the combination of experience and training will be taken under consideration • Minimum 5 years clinical research experience (e.g. pharmaceutical, biotechnology, CRO healthcare setting [including 2 +years monitoring experience is preferred]) • Ability to work on complex or multiple projects and exercise critical thinking • Knowledgeable in clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, as required • Solid organizational skills, interpersonal skills and communication skills (both written and oral) • Demonstrates problem solving skills, self-motivated and adaptable to a dynamic environment • Strong computer skills (Word Document, Smart Sheet, Excel and Power Point) • Experience in global trials preferred\ • Experience in interactions with vendors (e.g CROs, central laboratories, and other vendors preferred) • Ability to work in a dynamic, fast paced environment • Ability to deal with ambiguity
HAYS PLC • Rockville, U.S.
Notre client, biotech en pleine croissance & leader sur le marché des études précliniques, recherche actuellement son nouveau Directeur d’Etudes Précliniques. Le rôle est à pourvoir en CDI et basé dans la région Auvergne Rhônes-Alpes. Votre rôle :Vous assurerez en parallèle la réalisation de plusieurs études précliniques sur des modèles animaux permettant de répondre aux besoins clients.Vous serez l’interlocuteur principal de vos clients, pendant toute la durée des études. Profil :Habilitation en expérimentation animale niveau 1 (concepteur)Master à dominante biologiqueExpérience sur un rôle similaireAnglais professionnel
Approach People Recruitment • Lyon, France
Our client, one of the world´s leading pharmaceutical company, is currently looking for their future Methods Engineer.Your responsibilities:Provide technical leadership to identify, evaluate, and improve existing manufacturing processes.Collaborate for an effective development activity with Quality, R&D, Analytic, Validation group, Engineering Facilities and various vendors to develop and sustain manufacturing processes…Evaluate in collaboration with PPD if new or improved processes are compatible with the company manufacturing facilities and equipments. You will participate to first production batches and validate the transfer from PPD to manufacturing team.Provide support to new proOur client, one of the world´s leading pharmaceutical company, is currently looking for their Project Manager – Product Process Development.duct introduction, production process development, product transfers, and existing process sustainment.Manage the design and execution of manufacturing process (Preparation, Synthesis, Dialysis, degassing filling, sterilization, final packaging) and appropriate Verification/validation activities accordingly applicable procedures and regulations.Develop and/or review/approve documentation to support improved manufacturing processes per applicable procedures.Write and perform Validation plan strategy and process validations in collaboration with Validation team including methods for inspection.Participate to Risk process analysis and propose appropriate recommendations to mitigate risks.Work cross functionally with R&D, PPD and Quality to optimize processes, address yield and quality issues and drive implementation of solutions in a production environment to meet production goals (CAPA/ NCRB/ DCC meetings). Your profile : Engineering degree or equivalent.At least 5 years of relevant experience in production support/sustaining and/or process definition and development, design, scale-up, improvement and validation.lndustrial experience working in a GMP compliant setting.Experience leading cross-functional teams in the improvement and scale up of manufacturing processes.Experience with regulatory filings for Medical Devices and supporting regulatory inspectionsProject management in international environment focused on results.French -English speaking.
Approach People Recruitment • Ginevra, Svizzera
Role Description The Clinical Research Associate plays a vital role in the Clinical Operations team. Through responsibilities like monitoring studies, reviewing data, and engaging with sites, the CRA will ensure the success of clinical trial operations and management. • Monitoring clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a commercial benefit. This may include the following site visits: qualification, initiation, interim, and close out • Managing and training of site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion • Managing, preparing, sending, tracking, and returning investigational supplies at individual sites • Monitoring and documenting investigational product dispensing, inventory, and reconciliation • Monitoring and documenting laboratory sample storage and shipment Monitoring trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities • Reviewing source data and case report forms for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues • Reviewing data queries and listings, and working with the study centers to resolve data discrepancies • Reviewing regulatory documentation for accuracy and completeness, and supporting study centers with regulatory issues • Maintaining complete and accurate study files and reviewing files to ensure all appropriate documentation is present • Maintaining consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials. • Following Good Documentation Practices, completing Visit Reports and site correspondence in accordance with SOPs • No travel restrictions (i.e. willing to go anywhere in the US) Skills & Requirements • Minimum two years' ophthalmology monitoring experience- preferred specific indications would be Ph IIa dystrophy and Ph III nAMD (gene therapy); recent ophthalmology experience (cannot have been from 5+ years ago) • Solid tenures throughout their career- if they do not have strong tenure then we will need explain why candidate has jumped around and the reasons need to be valid • Bachelors Degree • CRO or Pharma experience
HAYS PLC • Raleigh, United States
Job SummaryThe Research Entomologist (Urban Entomology) will work closely with members of the marketing, formulations and regulatory teams to develop new products for an indoor insecticide portfolio. They will be involved in insect rearing and colony maintenance activities for the R&D insectary. They will partner with members of the R&D formulations team to set up and execute insecticidal efficacy trials at our Earth City Laboratory as well as coordinate third party efficacy testing with Contract Research Labs (CROs) and Universities. They will have a strong background in behavior and management of crawling insects, arachnids, and arthropods.Primary Duties & ResponsibilitiesCoordinate third party efficacy testing with CROs and professional pest control networkAnalyze data for claims substantiationGenerate data for new consumer claims or regulatory requirementsInsect rearing and colony maintenanceReview and update procedures vs. federal EPA efficacy guidelinesPrototype and screen efficacy for new product innovationPartner with formulators to recommend and evaluate various active ingredientsMaintain detailed and accurate records of experimental trials, summarize trial results, and assemble study reportsScan competitive activityWork with laboratory personnel to conduct biological efficacy trials that require the handling of insects and insecticides.Support outreach and product education activitiesUS travel to CROs, strategic partners, organized, conferences and meetingsOther duties as assigned.Education and Experience ProfileBachelor’s Degree in Entomology, Biology, or a related science with 3+ years of laboratory experience.Understanding of common urban / structural pest biology.Good Laboratory Practice (GLP) knowledge.Experience in ants, spiders, and common household crawling insects a plus.Experience in product development.Required SkillsDetail oriented.Strong oral and written communication skills.Ability to organize and carry out concurrent projects according to appropriate guidelines and protocols.Ability to work with insects and insecticides on a regular basis in a controlled environment.Ability to collaborate and work effectively with others to achieve results.Work EnvironmentApproximately 80% laboratory/office environment and up to 20% travel
Glassdoor Inc. • Saint Louis, U.S.